RAC Post-Market Requirements 1

Question 1

What is pharmacovigilance?

Accepted Answer

Monitoring drug safety after approval

Answer

Marketing surveillance

Answer

Post-approval testing

Answer

Advertising compliance

Question 2

Which form is submitted to the FDA to report an adverse drug event?

Accepted Answer

Form FDA 3500

Answer

Form FDA 356h

Answer

Form FDA 1571

Answer

Form 483

Question 3

What is the purpose of Risk Evaluation and Mitigation Strategies (REMS)?

Accepted Answer

Ensure safe use of high-risk medications

Answer

Speed up clinical trials

Answer

Encourage over-the-counter use

Answer

Simplify manufacturing

Question 4

Which of the following is part of post-market surveillance for medical devices?

Accepted Answer

Post-market surveillance and reporting

Answer

Device classification

Answer

IDE submission

Answer

Patent renewal

Question 5

What is a Class I recall?

Accepted Answer

Potentially serious health risk

Answer

Cosmetic labeling issue

Answer

Technical specification update

Answer

Voluntary return for review

Question 6

Which post-market requirement ensures continued compliance with good manufacturing practices?

Accepted Answer

FDA inspections and audits

Answer

Patent check

Answer

Marketing approval

Answer

Annual sales report